Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions

Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions explains the role of alternative approaches to bioequivalence across various dosage forms, route of administration and regulatory bodies with an ultimate aim of reducing clinical trial and bioequivalence study burden encompassing human volunteers. There is a growing awareness on minimizing the role of human volunteers, especially healthy human volunteers, in drug testing for studying the sameness of a new product with that of existing approved product. This book covers several administration routes and deals with biowaivers for dosage form, routes of administration and geographical jurisdiction. Divided into five sections, including oral drug products, ophthalmic drug products, topical and transdermal drug products, orally inhaled and nasal drug products, and complex injectables, this book includes multiple real-world case studies alongside theory and protocols. Perspectives on Bioequivalence Pathways for Drug Product Approval: Across Dosage Form, Route of Administration and Geographical Jurisdictions focusses on alternative bioequivalence approaches that can be fostered to minimize human testing along with instigating new ideas and opening new avenues for the development of such approaches. It will be useful to pharmaceutical scientists working to produce affordable medicines to all as well as regulatory agencies, pharmaceutical companies, formulation scientists, clinical scientists would get benefited by the book, as it would help in designing the clinical strategy for the product in terms of highlighting the bioequivalence against available marketed product. Covers different administration routes and different jurisdictions in a single sourceIncludes all relevant case studies and requirements/understandings of various global regulatory bodiesDeals specifically with biowaivers for dosage form, routes of administration and geographical jurisdiction INDICE: Section 1: Bioequivalence Pathways for Oral Drug Products across regulatory bodies with relevant case studies 1. BCS based biowaiver approaches 2. Safe Space based approaches 3. Bioequivalence for drug products acting locally in GI tract Section 2. Bioequivalence Pathways for Ophthalmic Drug products across regulatory bodies with relevant case studies 4. Ophthalmic Gel Products 5. Ophthalmic Emulsions  6. Ophthalmic Suspensions Section 3. Bioequivalence Pathways for Topical and Transdermal Drug products across regulatory bodies with relevant case studies  7. Topical Gel Products 8. Topical Cream Products 9. Nail Drug Products and possible approaches 10. Pediculicide hair tuft assay based approaches 11. Transdermal Drug products 12. PBPK Approaches For Topical Drug Products Section 4. Innovative Bioequivalence pathways for Topical drug products 13. Dermal Microdialysis 14. Dermal Open Flow Microdialysis 15. Tape stripping based approaches 16. Antimicrobial kill rate studies for dermal products Section 5. Bioequivalence Pathways for Orally Inhaled and Nasal Drug Products across regulatory bodies with relevant case studies 17. Dry Powder Inhalers for Lung Diseases In vitro considerations for DPI 18. BE Assessment for Inhalational Products 19. Nasal Sprays 20. Computational Fluid Dynamic based approaches for Absorption Prediction for Orally Inhaled and Nasal Products Section 6. Bioequivalence Pathways for Complex injectables across regulatory bodies with relevant case studies 21. Liposomal Drug products 22. Injectable Microsphere and In Situ Implants 23. Injectable Suspensions 24. Injectable Emulsions

• ISBN: 978-0-12-824141-7
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 675
• Fecha Publicación: 01/11/2021
• Nº Volúmenes: 1
• Idioma: Inglés